Axelon Services - Contract
DescriptionThe Technician is a position reporting to a Process Execution Team Facilitator, which supports Formulation/Buffer operations. The position entails the execution of setup, changeover, for all equipment used in the production processes in various Classified/Non-Classified areas. It requires the ability to assist with mechanical and electronic troubleshooting in order to ensure optimal operation of equipment via OEE. The Technician will also serve as a resource to implementation of continuous improvement projects.
- Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
- Perform 5S activities and maintain organization of operating areas.
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.
- Be familiar with “Material Safety Data Sheets” for area chemicals.
- Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed.
- Responsible for outgoing quality level.
- Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET.
- Work with minimal supervision under the direction of the shift lead, Process Facilitator, Engineer, or other activity lead.
- Perform roles as required to support daily PET activities.
- Set-up equipment and perform required adjustments to ensure each operation is performing per process specifications.
- Utilize appropriate Problem Solving and Troubleshooting techniques as needed.
- Serve as a resource to PET to assist in the follow up and timely implementation of projects and validation activities.
- Responsible for maintaining Processing and Gowning certifications as required to support assigned work areas.
- Perform other similar and related responsibilities as assigned by area management.
- Strong verbal and written communication skills
- Proven ability to work effectively in a team environment
- Strong mechanical/technical aptitude
- Ability to interpret technical documents
- Candidate should possess the ability to work in a changing/demanding environment.
- High school graduate, vocational school graduate or equivalent
- Minimum one year experience in a regulated production environment
- Previous experience with automated equipment preferred
- Knowledge of data and materials maintenance systems such as SAP or other MRP systems
- Experience with OEE, LEAN or other Continuous Improvement systems.